Drug Safety Assistant

Perform activities required to manage safety data.

RESPONSIBILITIES:

- Monitor and manage dedicated drug safety mailboxes
- Maintain local documentation as required by legislation (including archiving/tracking/retrieval) - lifting of boxes
- Support the submission and distribution of reports and relevant tracking
- Support distribution and tracking of distribution of Follow-Up letters
- Support inspection preparedness activities policies and practices as per Company SOPs
- Consistently apply Archiving policies as per Company SOP.

SKILLS:

- Basic understanding of Pharmacovigilance
- Demonstrated computer literacy
- At least 2 years' experience in the use and management of relational databases
- Ability to solve problems constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a Matrix organization
- Fluency in spoken and written English
- 1-3 year Drug Safety experience
- Must be local to Bridgewater, NJ
- Understanding of International Regulatory/Safety Regulations and Guidelines is desired
- Experience with MS Excel, MS Outlook, and MS Word is desired
- Regulatory Documentation experience is desired